SOFT PLUG ABSORBABLE PLUG-SA by OASIS MEDICAL, INC.

The OASIS Medical Soft Plug® Absorbable Plug - SA is intended for temporary use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by blockage of the canaliculus. It may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases. When indicated, the OASIS Medical Soft Plug® Absorbable Plug - SA may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye.

Device Description

The proposed device, the Soft Plug® Absorbable Plugs - SA, is substantially equivalent in intended use and operation to the various collagen intracanalicular plugs in the market today. These include the Soft Plug Collagen Intracanalicular Plug by OASIS Medical (K946357), the Temporary Intracanalicular Plug by Eagle Vision (K890919), and the Collagen Implants For Use in the Lacrimal Efficiency Test™ by Lacrimedics (K895342). All of these plugs are 2 mm long and are cut from non-sterile suture material. The implants are intended to be inserted into the canaliculus to block fluid flow for a temporary period of time (less than 3 months based on results obtained in an animal study) until they are absorbed. The only difference is the type of absorbable suture they are cut from, polyglyconate versus collagen, and the length of time they will take to absorb, less than 3 months versus several days.

The proposed device, the Soft Plug® Absorbable Plugs - SA, is also similar in intended use and operation to the Herrick Lacrimal Plug™ by Lacrimedics (K896175). This is a silicone intracanalicular plug intended for insertion into the canaliculus to permanently block fluid flow. It approximates the size of the absorbable plugs mentioned above.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a comprehensive study report with all the requested information for the Soft Plug® Absorbable Plugs - SA. However, I can extract the available information and highlight what is missing.

Available Information and Missing Details:

Here's a breakdown based on the provided text, addressing each requested point as much as possible:

Table of Acceptance Criteria and Reported Device Performance:

The text does not explicitly state formal "acceptance criteria" in a tabular format with quantitative targets for the device's performance. Instead, it describes the results of a human clinical study in qualitative terms and compares absorption time to predicate devices.

Acceptance Criterion (Inferred)	Reported Device Performance
Biocompatibility	No evidence of antigenicity, systemic toxicity, carcinogenicity, mutagenicity, tetratogenicity, or adverse effects on reproductive performance (pre-clinical testing).
Retention Time	Remained in place for two months in rabbit canaliculus. All gone by third month (animal study).
Comfort Level	Most patients unable to differentiate between Soft Plug® Absorbable Plugs - SA and collagen plug; reported same comfort level for both eyes.
Efficacy (Subjective Relief)	All patients showed signs of improvement as a result of the treatment. Subjective relief persisted for at least one month.
Complications/Adverse Events	None reported in the clinical study.

Missing: Specific quantitative thresholds for comfort, efficacy, or retention time that would constitute "acceptance."

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 40 dry-eye patients for the double-blind clinical study.
- Data Provenance: The text does not explicitly state the country of origin. It indicates a "double-blind study involving 40 dry-eye patients." It is a prospective clinical study.
- Animal Study: The pre-clinical testing involved "polyglyconate plugs inserted into the rabbit canaliculus," indicating an animal model. No specific number of rabbits is given.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the text. The study describes patient-reported comfort and "signs of improvement," likely assessed by the investigating clinicians, but there's no mention of a ground truth established by a panel of experts.
Adjudication Method for the Test Set:

This information is not provided in the text. Given the nature of this device (intracanalicular plug), it's unlikely that a formal adjudication method (like 2+1 or 3+1 for imaging studies) would be directly applicable for assessing subjective patient relief or comfort.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:

This is not applicable. The device is an intracanalicular plug, not an AI software/algorithm. Therefore, an MRMC study related to AI assistance is irrelevant to this device.
If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:

This is not applicable. The device is a physical medical device (an absorbable plug), not an algorithm or AI software. Therefore, "standalone" performance in the context of an algorithm is not relevant.
The Type of Ground Truth Used:
- For the human clinical study: The "ground truth" seems to be based on patient-reported comfort and subjective relief, along with clinical observation of complications/adverse events by the treating clinicians.
- For the animal study: The ground truth for retention time was likely direct observation of the plugs in the rabbit canaliculus over time. Biocompatibility was assessed through various tests (antigenicity, toxicity, etc.).
The Sample Size for the Training Set:

This is not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.
How the Ground Truth for the Training Set Was Established:

This is not applicable for the same reason as point 8.

Summary of Study Details:

Study Type: Double-blind clinical study (human patients), pre-clinical animal study.
Human Study Design: Compared Soft Plug® Absorbable Plugs - SA (in one eye) to a collagen plug (in the other eye) in the same patient.
Human Study Duration: Evaluated monthly over a period of four months.
Key Findings (Human Study):
- No complications or adverse events.
- All patients showed signs of improvement.
- Most patients could not differentiate between the two types of plugs and reported similar comfort levels.
- Subjective relief persisted for at least one month.
Key Findings (Animal Study - Rabbit):
- Polyglyconate suture produced no evidence of antigenicity, systemic toxicity, carcinogenicity, mutagenicity, tetratogenicity, or adverse effects on reproductive performance.
- Plugs remained in place for two months, and all were gone by the third month, indicating absorption. This residency time was between short-term collagen plugs and permanent silicone plugs.

Summary

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510-528 S. Vermont Avenue Glendora, CA 91741 (626) 914-2891 FAX (626) 914-2285

510(k) SUMMARY

Date Submitted:

By:

Oasis Medical, Inc. 514 S. Vermont Avenue Glendora, CA 91741

June 25, 2002

Yvonne Fernandez Contact Person:

Soft Plug® Absorbable Plugs - SA Trade Name:

Common Name: Intracanalicular Plug/Punctum Plug
Classification Name/Product Code: Punctum Plug/86LZU

Soft Plug® Absorbable Plugs - SA

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Image /page/1/Picture/0 description: The image shows the word "OASIS" in a stylized font, with a palm tree above the letter "A". The letters are thick and black, with a slightly textured appearance. The palm tree has a cluster of leaves at the top and a trunk that extends down to the top of the letter "A".

Glendora, CA 91741 510-528 S. Vermont Avenue (626) 914-2891 FAX (626) 914-2285

Pre-clinical testing on polyglyconate suture produced no evidence of antigenicity, systemic toxicity, carcinogenicity, mutagenicity, tetratogenicity, or adverse effects on reproductive performance. Polyglyconate plugs inserted into the rabbit canaliculus remained in place for two months. By the third month, all of the plugs were gone from the canaliculus. This residency time falls between the absorbable collagen plugs, which are several days, and the Herrick plug, which is designed to remain permanently in the canaliculum.

A double-blind study involving 40 dry-eye patients was conducted which compared a Soft Plug® Absorbable Plugs - SA placed in the lower canaliculus of one eye to a collagen plug placed in the lower canaliculus of the other eye. Each patient was evaluated at the start of the study and aqain at monthly intervals over a period of four months.

None of the plugs were removed. There were no complications or adverse events. All of the patients showed signs of improvement as a result of the treatment. Most patients were unable to differentiate between the Soft Plug® Absorbable Plugs - SA and the collagen plug and reported the same comfort level for both eyes during the monthly examinations. In the clinical study, the subjective relief achieved from both plugs persisted for at least one month.

Yvonne Fernandez

6/25/02
date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2002

Oasis Medical, Inc. c/o Ms. Yvonne Fernandez Director, RA/QA 514 South Vermont Avenue Glendora, CA 91741

K013613 Re:

Trade/Device Name: Soft Plug® Absorbable Intracanalicular Implants - SA Regulation Name: Plug, punctum Regulatory Class: Unclassified Product Code: LZU Dated: March 29, 2002 Received: April 2, 2002

Dear Ms. Fernandez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/4/Picture/0 description: The image shows the word "OASIS" in a stylized font, with a palm tree above the letters. The letters are bold and have a textured appearance. The palm tree is silhouetted and positioned above the "A" in "OASIS". The overall design has a tropical or vacation-themed feel.

510-528 S. Vermont Avenue Glendora, CA 91741 (626) 914-2891 FAX (626) 914-2285

OASIS Medical, Inc. Soft Plug® Absorbable Plugs - SA Indications For Use

510(k) Number K013613

Device Name: Soft Plug® Absorbable Plugs - SA

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

free opt-out and free opt-in

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma

(Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devise

510(k) Number_K013613

Prescription Use: x (Per 21 CFR 801.109)

OR Over The Counter Use: (Optional Format 1-2-96)

Regulation Number and Section

N/A